© 2004 by Oxford University Press
© 2004 Oxford University Press
IN THIS ISSUE |
State-Mandated Reimbursement for Cancer Trial Participation
An often-cited barrier to enrollment in cancer clinical trials is payer reimbursement. Gross et al. (p. 1063) examined if state mandates ensuring coverage of routine medical care costs of cancer trial participants increased patient enrollment rates for National Cancer Institute–sponsored phase II and cooperative group phase III trials between 1996 and 2001. They compared enrollment of participants in four states that had enacted coverage policies in 1999 with enrollment in states without policies. After the state mandates were enacted in 1999, the authors found that phase II trial enrollment increased at a greater rate in states with coverage policies compared with states without policies. However, phase III trial enrollment increased at a similar rate in all states, suggesting that coverage mandates were not associated with an increase in phase III trial enrollment.
In an editorial, Hillner (p. 1048) addresses the effect of state mandates that cover patient care costs of clinical trial participation on trial enrollment. He discusses the issue of cost as a barrier to enrollment as well as other potential enrollment barriers.
Lung Cancer Histologic Type in SEER vs. Independent Review
Because few studies have assessed the accuracy of lung cancer histologic types reported in state cancer registries, Field et al. (p. 1105) examined whether the lung cancer histologic diagnoses were reliably reported in the Iowa Surveillance, Epidemiology, and End Results (SEER) Cancer Registry. They investigated the agreement between histologic types reported for 413 patients with lung cancer by the Iowa SEER Cancer Registry and those obtained through an independent review of diagnostic slides from the Iowa Radon Lung Cancer Study. They found that small-cell carcinoma had the highest sensitivity, positive predictive value, and percent exact agreement, compared with large-cell carcinoma, adenocarcinoma, and squamous carcinoma. They also found that samples from cytologic or biopsy examination were more likely to be misclassified than samples obtained from resection. They conclude that the histologic type obtained by the Iowa Cancer Registry was reasonably reliable but that independent slide review is needed for precise histologic typing of lung cancer.
In an editorial, Henson and Albores-Saavedra (p. 1050) note that, because SEER serves as the national database, it places a heavy responsibility on pathologists to ensure that the diagnostic information provided to SEER is accurate and based on meaningful classification systems. Nevertheless, they say, the regression of large numbers is taking effect as the SEER Program matures and the patterns of histologic tumor types are converging to their mean.
HAART, SIL, and HIV-Positive Women
Women infected with the human immunodeficiency virus (HIV) have an increased risk of persistent squamous intraepithelial lesions (SILs) of the cervix. Ahdieh-Grant et al. (p. 1070) assessed the association between use of highly active antiretroviral therapy (HAART) and regression of SIL in HIV-infected women enrolled in the Women's Interagency HIV Study. The authors found that the incidence of regression increased from 0.0% before HAART was introduced to 12.5% after HAART was introduced, and regression was related to post-HAART CD4+ T-cell counts. The authors conclude that HAART use was associated with increased regression of SIL among HIV-infected women, and, among women who used HAART, increased CD4+ T-cell counts were associated with a greater likelihood of regression. However, the majority of cervical lesions among HIV-infected women, even among individuals who used HAART, did not regress to normal.
In an editorial, Xi and Kiviat (p.1051) discuss whether HAART alters the natural history of SIL among HIV-infected women and provide some perspective on the long-term consequences of HAART for these women.
Conventional vs. High-Dose Therapy for Breast Cancer
Because uncontrolled studies of high-dose chemotherapy for breast cancer patients with four or more positive axillary lymph nodes produced much better results than conventional therapy, Leonard et al. (p. 1076) designed a prospective, randomized trial to compare a single-cycle of high-dose chemotherapy with conventional chemotherapy in high-risk patients with breast cancer. At a median follow-up of 6 years, they detected no statistically significant difference between the groups for 5-year relapse-free survival or overall survival. They conclude that high-dose therapy is not superior to conventional chemotherapy in patients with breast cancer who have multiple involved lymph nodes. They also caution that this conclusion should be viewed in the context of improving the success of conventional chemotherapy.
Quality of Life and Adherence in a Screening Trial
Clinical studies have shown that cancer screening has the potential to affect health-related quality of life (HRQL) and subsequent screening behaviors. However, little is known about HRQL and screening adherence in the context of randomized screening trials. One such study is the PLCO, a large cancer screening trial designed to assess whether annual screening for prostate, lung, colorectal, and ovarian cancer reduces mortality from these diseases. In this issue (p. 1083), Taylor et al. report findings from an ancillary study within the PLCO in which they assessed the impact of participation in PLCO on both HRQL and adherence. Participants in both the screening and control arms reported high levels of HRQL. Abnormal screening results were related to short-term HRQL but not intermediate-term HRQL. Trial adherence was better among participants who received all normal results in the previous year's tests than among those who had received at least one abnormal result.
Breast-feeding, Breast Cancer, and BRCA Mutations
Studies in the general population have shown a decreased risk of breast cancer with increasing duration of breast-feeding. Jernström et al. (p. 1094) conducted a case–control study to determine whether breast-feeding is associated with a reduced risk of hereditary breast cancer in women who carry deleterious BRCA1 and BRCA2 mutations. The authors found that, among women with BRCA1 mutations, the total duration of breast-feeding, which was shorter for case subjects than for control subjects, was associated with a reduced risk of breast cancer. Women with BRCA1 mutations who breast-fed for more than 1 year in total during their lifetime were less likely to have breast cancer than those who never breastfed, although no such association was seen for women with BRCA2 mutations.
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